Human Subjects/IRB

University of Massachusetts Institutional Review Board

Suicidal Ideation Response Guidance

Suicide is a leading cause of death in the United States, with 45,979 deaths in 2020.[1] The University of Massachusetts Amherst Institutional Review Board (IRB) supports research initiated by investigators aimed at better understanding the factors associated with self-harm, suicidal ideation, and suicide. At the same time, the IRB has an important role in advocating for the health and safety of research participants. IRB deliberations must carefully weigh the importance of the research in this area and our desire to avoid placing barriers to suicide research with participant welfare and the safeguarding of vulnerable populations. The IRB often reviews research protocols utilizing surveys and “questionnaires focused on mental health, psychological functioning, and mood. Some of those studies focus directly on suicidal thoughts and behaviors or include one or more individual questions about suicidality. Research protocols that involve the identification of suicidal ideation in participants raise concerns about potential risks for those participants. Even though empirical research has shown that asking about suicidality does not increase suicidal risk (Dazzi et. al. 2014), research studies that include assessments of suicidality require additional monitoring of participants’ responses, as further detailed below.”[2]  This guidance gives the general action plans that will be required for all studies that involve questions about suicidality, but is particularly meant to support researchers who are not experts in the specific field of depression and suicidality.   

Action Plan

The centerpiece of any study which includes prompts regarding self-harm, suicidal ideation, or suicide will be an IRB-required “Action Plan.” The IRB will require that you develop an “Action Plan” addressing several contingencies in order to provide support and resources to any participant disclosing that they may be at risk of imminent harm. “Imminent risk” must be defined by the researcher and refers to a heightened and concerning desire or intent to self-harm; as such, the definition of “imminent risk” may vary depending on the measure or question(s) administered by the researcher, but the IRB will consider daily or nearly daily thoughts of suicide or the existence of a plan to carry it out as imminent risk requiring action. If researchers are unsure how they would identify imminent risk, it is advisable to work with an expert in the field of suicide studies and suicidal intent. While the IRB is also concerned when a participant expresses any suicidal ideation, it is imperative that timely action is taken when the participant discloses imminent risk of suicide or other self-harm.

The “Action Plan” should at a minimum address the following points:

  1. Ensure that the question(s) asking about self-harm or suicidal ideation are reviewed as soon as possible but no longer than 24 hours after the participants’ response being captured.
  2. Ensure that anyone who expresses a high degree of suicidal ideation or self-harm is identified (when participants are identifiable) and provided help. If the participants are students and with the researcher, the help should be really hands on and immediate (consulting the “Maroon folder,”calling emergency services, walking them to the CCPH if necessary, etc.). In the case of remote methods (surveys, etc), there should be outreach to the participant and services sought for them.  The plan should also mention whether confidentiality will be broken in such instances and the consent documents should disclose under what circumstances confidentiality will be broken.
  3. If the participants are not students, they should be referred to mental health resources, and if the threat is considered imminent, confidentiality should be broken, and emergency medical services engaged. All consent documents should also make clear that in these instances confidentiality cannot be assured, and mental health or other medical services may be alerted.

General Considerations:

Including Suicide Measures:

  • If using a measure such as the Beck Depression Inventory or the Patient Health Questionnaire-9, consider whether the questions about suicidality are necessary; of course, such questions are important for research on depression and suicidality, but for studies that are not focused on these topics, the researcher may decide that either another measurement would be a more appropriate “fit” for their study, or may consider whether individual questions can potentially be omitted from standard instruments if they are not relevant to the study, with the rest of the instrument being used.  These decisions are ones for the researcher to consider. When considering altering an instrument, check the copyright status of the measure to see if it can be modified and consider whether the removal of questions would undermine the instrument’s validity as a diagnostic tool for the research at hand.

Populations Involved:

  • Consider the populations involved in the study; certain groups have higher likelihood of experiencing suicidal ideation and/or intent.  These populations may require additional protections, and/or additional training to ensure cultural sensitivity.  If working with these populations and asking personal/sensitive questions, such as questions about personal history and emotional states – even if suicide is not explicitly asked about – a clear Action Plan should be outlined in the protocol’s “Risks and Risk Management” section, and the informed consent document should make it clear that confidentiality may be violated if a risk to self or others is disclosed.
  • If children are being asked questions involving suicide, the parental consent form and child assent form should both contain all of the following: the fact that there will be questions about suicide; the Action Plan for imminent risk, if the child indicates being suicidal; and when/how parents/guardians will be informed of a finding of such imminent risk.  If working in partnership with schools, additional precautions and support services might be necessary, and any FERPA regulations that would be enacted should be considered.
  • For actively suicidal populations, several additional factors may be considered including ability to consent (this may be dictated by state law in cases where individuals are involuntarily committed to psychiatric facilities or hospitals) and concerns about access to firearms if and when imminent risk of suicide has been determined (researchers should check ahead of time for ‘red flag’ laws within the state at the time of the research study).

Databases:

  • Note that questions about suicidal ideation and intent asked on subject pool screening forms/databases such as SONA would still need to be checked within a 24 hour period; for this reason, most databases choose not to collect such data.

Research Pre-planning:

  • Although research has shown that asking about suicidality does not increase risk, studies that include questions about suicide and assessments of suicidality require additional monitoring of participants’ responses for their safety.  Keep in mind that for UMass Amherst research studies, non-anonymous surveys and interviews with questions about suicide must be checked within 24 hours; this includes both weekdays and weekends.  This policy is in line with other major institutions.  Please take this into consideration when planning for staffing, hourly work, vacation time, etc.
  • For studies that involve technological data gathering and/or interventions around suicidality, the protocol to the IRB should include a summary of how the system has been tested prior to deployment (beta tests with software, stress tests, field tests with hardware, etc) as well as how the systems will be regularly monitored while the study runs (i.e., regular accuracy checks and a plan to identify and correct problems in a timely fashion).

NIH Considerations:

  • NIH funded studies of suicide may require additional staffing (such as medical monitors and/or Data and Safety Monitoring Board experts) and data sharing plans.

Anonymous Surveys with Questions about Suicide:

  • the informed consent document/page should make it clear that researchers will not be able to link responses to any individual, and will not be able to reach out to provide any support services if suicidal ideation is reported
  • informed consent must let participants know that questions about suicide will be asked
  • a list of support services should be provided to every participant at the beginning of the survey (and potentially at the end of the study as well, if the researcher would like to provide them a second time)
  • if the survey is lengthy (15 minutes or longer) and asks about suicidal ideation at different points, it is advisable to provide periodic links to support services throughout the survey
  • the researcher should be prepared to offer, in the protocol, a justification for why the benefits of asking such questions in an anonymous survey outweigh the risks

Identifiable Online Surveys with Questions about Suicide:

  • informed consent/page must let participants know that questions about suicide will be asked
  • the informed consent document must state that confidentiality may be broken if suicidal intent is disclosed, and that outreach and an assessment from the research team will follow; describe the procedures if a participant cannot be reached for assessment
  • all submissions of the survey must be reviewed for suicide-related questions within 24 hours of their submission
  • the protocol must describe the score at which a participant is considered at imminent risk of suicide, who will do this evaluation and what their training background is, how the participant will be reached, and what the Action Plan will entail
  • for non-imminent cases, a list of resources may be shared directly with the participant
  • for imminent cases, a clear Action Plan must be submitted in the protocol and outlined in the informed consent document

Non-Anonymous In-Person Surveys and Interviews

  • informed consent/page must let participants know that questions about suicide will be asked
  • the informed consent document must state that confidentiality may be broken if suicidal intent is disclosed and what the treatment plan would entail
  • when partnering with clinical systems, the informed consent document and protocol should outline how patient information is shared and how a positive risk screen will be handled
  • responses to any survey items regarding suicidality and depression must be reviewed before the participant physically leaves the space
  • the protocol must describe the score at which a participant is considered at imminent risk of suicide, who will do this evaluation and what their training background is, and what the Action Plan will entail
  • for non-imminent risk, a list of resources should still be shared with the participant; if working with UMass Amherst students on campus, an offer should be extended to connect them with staff at CCPH, by email/referral or by walking them there
  • for imminent risk, the researcher must remain with the participant until official support services have been received; for students on campus, this should entail walking them directly to CCPH; off campus and for non-students, this might entail emergency services.  Note that having a family member or friend come to the participant, on its own, is not an official support service.

Reportable Events

  • a disclosure of suicidal intent may or may not count as a reportable event depending on the aims of the research study; for instance, a study whose primary research questions are around suicidality and involves only populations at a known high risk of suicide (such as individuals with recent suicide attempts) would not report suicidal ideation as an event, whereas a study about family histories wherein a participant disclosed strong depressive feelings and suicidal intent would, as it is “unexpected” in that study context; this would be reported if there is a concern that the suicide attempt is linked to the subject’s involvement in the study

Depression Guidance:

  • Some studies will ask questions about depression, but not specifically suicide.  For identifiable participant responses to standardized measures (for instance, the Beck Depression Inventory), consider what responses will trigger a concern about depression, who will assess this, and what their training is.  For mild depression, no intervention from the researcher is necessary.  For moderate to severe depression findings, a list of resources should be provided.  The researcher may choose to provide resources to all participants.  The researcher can compile a list that is most relevant for the study population (for instance, UMass Students may be directed to CCPH, the Women’s Center, the Stonewall Center, etc; national studies may reference the 988 hotline, and so forth).  Informed consent forms for studies with questions about depression should indicate that the researchers are not clinicians and will not be following up about participants’ possible depression scores.

 

References:

Children’s Hospital of Philadelphia Behavioral Research. (2021.) Participants with Unexpected Suicide Risk. https://www.research.chop.edu/services/behavioral-research

Committee for Protection of Human Subjects. (2017.) Suicidal Ideation in Protocols. https://cphs.berkeley.edu/suicidal_ideation.pdf

Cornell University Office of Research Integrity and Assurance. (2017.) Managing Risk of Harm to Self or Others. https://researchservices.cornell.edu/sites/default/files/2019-05/IRB%20Guidance%20on%20Managing%20Risk%20of%20Harm%20to%20Self%20or%20Others.pdf

Dazzi, T., Gribble, R., Wessely, S., and Fear, N.T. (2014.) Does asking about suicide and related behaviours induce suicidal ideation? What is the evidence? Psychological Medicine. https://www.researchgate.net/profile/Rachael-Gribble/publication/263709839_Does_asking_about_suicide_and_related_behaviours_induce_suicide_ideation_What_is_the_evidence/links/53f315160cf2dd48950c8ae1/Does-asking-about-suicide-and-related-behaviours-induce-suicide-ideation-What-is-the-evidence.pdf

Duke University Institutional Review Board. Including Questions about Suicidal Ideation in Research with Undergraduates. https://campusirb.duke.edu/irb-policies/including-questions-about-suicidal-ideation-research-undergraduates

Mirick, R. Salem State Suicide Guidance. https://elearning.salemstate.edu/courses/1110675/pages/suicide-guidance-anonymous-survey

National Institute of Mental Health. (2021.) Conducting Research with Participants at Elevated Risk for Suicide: Considerations for Researchers.  https://www.nimh.nih.gov/funding/clinical-research/conducting-research-with-participants-at-elevated-risk-for-suicide-considerations-for-researchers

Northwestern University IRB Guidance on Suicidality in Human Research Protocols. https://irb.northwestern.edu/resources-guidance/policies-guidance/docs/guidance-on-suicidality-in-human-research-protocols-1915.pdf

University of Pennsylvania Human Research Protections Program. (2022.) Suicidal Ideation and Behavior: Risk Mitigation Guidance. https://irb.upenn.edu/documents/suicidal-ideation-and-behavior-risk-mitigation-guidance/

University of Wisconsin Health Sciences Institutional Review Boards. (2019.) Identification of Suicidality or Major Depression Guidance. https://kb.wisc.edu/hsirbs/page.php?id=19556

 

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Adverse event reporting to the IRB, and in some circumstances, Federal agencies and the Sponsor, is required by Federal regulation.  The UMASS IRB has established the following policies and procedures for the reporting of adverse events as a means of ensuring that the risks and benefits relationship to subjects participating in research studies remains acceptable, and the consent form contains information necessary for subjects to make an informed decision about their participation or continuation in a study. Adverse event reporting requirements differ depending on the nature of the study.

Federal regulations [45CFR46.103(b)(5) and 21CFR56.108(b)(1)] require the IRB to ensure that investigators promptly report "any unanticipated problems in involving risk to subjects or others." All adverse events as defined below must be reported to the IRB. The type of event as defined below determines the reporting requirements:

1. Significant Adverse Events

Investigators must report the event as soon as possible, but no later than five (5) weekdays after first awareness of the problem. Significant adverse events include, but are not limited to:

a. any death, excluding death due to the progression of a disease process; OR

b. the combination of the following three conditions:

  • unexpected - any adverse experience that is not identified in nature, severity, or frequency in the consent form, and is not due to the progression of a disease process.
  • serious – includes, for example, any experience that is fatal or life threatening, is permanently or significantly disabling (physically or psychologically), requires inpatient hospitalization or prolongation of hospitalization, contributes to a congenital anomaly/birth defect or is any medical event that requires treatment to prevent one of the medical outcomes listed above.
  • related/possibly related – as determined by the research team.

The same type of events from another study site should also be reported to the IRB within ten (10) weekdays of receipt.

The IRB relies a great deal on the expertise of our investigators to assess SAEs. Therefore, the investigator must provide advice concerning:

  • the relationship of the SAE to the drug, device, intervention, or study protocol
  • whether or not a change in protocol is necessary to minimize risks, and
  • whether or not information about the SAE is relevant to consent and/or re-consent of participants already enrolled.

Reporting Requirement

Once the Principal Investigator (PI) determines that an adverse event meets the IRBs’ reporting requirements, he/she must report the SAE, and related safety information, to the IRB on the required. Supporting documents, including a copy of the Informed Consent (IC), should also be attached. For reasons of confidentiality, subjects names must not be included in the report. If the adverse event results in the need to revise the informed consent, or other study documents, the PI must submit a study amendment to the IRB.

2. Trends in One Type of Event

Any new trend toward one type of adverse event within a protocol, serious or not, should be reported to the IRB as soon as the trend is noted. This includes a trend in an expected side effect or noted risk that has created concern.

3. Other Adverse Events

All events that do not meet the criteria of significant or trends as listed in numbers 1 and 2 above, should be recorded in summary form. Reporting Requirements  All non-significant adverse events occurring in the research and judged by the research team to be related/possibly related to the research protocol should be recorded in summary form and included with the yearly Continuing Progress Report and at the close of the study. 

4. IRB Actions

Significant Adverse Events reports are immediately forwarded to Human Subject Administrator and IRB Chair. Reports result in the following actions:

  • Accept the report – no further action required.
  • Request additional information pending final action.
  • Recommend review by the original IRB reviewer(s) or the full IRB for possible action.
  • Require information concerning the adverse event be provided to subjects or others when such information may relate to their willingness to continue to take part in the research. In some cases, this may require changes in the informed consent, protocol, or other study documents, which may require reconsenting currently enrolled subjects.
  • If reviewed at a full IRB meeting, the Board may reconsider approval of the study, including suspension and/or termination, if it is determined that the adverse event has resulted in an increased risk to the subjects. In some cases, this could mean modifying (shortening) the continuing review cycle.

5. Reporting to the Sponsor

In accordance with the terms of the Federal Wide Assurance, the Office for Human Research Protections (OHRP) and the Federal Drug Administration (FDA) are notified in a timely manner of 1) serious or continuing noncompliance; 2) significant adverse events involving risk to participants or others; or 3) suspension or termination of IRB approval for a study. Unexpected problems involving risk, unless the event is serious and related to the research, are not routinely submitted to the sponsor.

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Just like payment, extra credit remuneration should not be so high that research subjects accept risk or discomfort they would not accept in the absence of remuneration.  This means that extra credit for research participation should not be a large percentage of the student’s overall grade.

Remuneration must be equal for all participants.  That means, for instance, that a professor cannot offer 1% of a student’s current course grade for filling out a survey, since that would differ from student to student.  A professor could offer 1% of the total possible course grade, so that each student who participates sees their final course grade go up by 1 percentage point.  

Importantly, if extra credit is offered in exchange for research participation, other students in a class must be given an alternate, non-research option for earning extra credit.  This extra credit option should take the same amount of time as the research option, and be worth the same amount of extra credit.  The alternate option should not be graded, as the research participation would not be graded.  Students should not be allowed to do both the research option and the alternate option for extra credit.

Consider difficult situations that may arise; for instance, what to do with a student who fills out half of a survey and then decides that they are uncomfortable continuing.  Will this student still get the extra credit for participating in research?  In general, it is better to allow students to receive the promised extra credit for the time they spent attempting the research activity, so that they are not penalized for discontinuing participation.  However, if there is any scenario where a student will not be given the extra credit – such as failing attention-check questions in a survey – this should be clearly stated in the informed consent document at the beginning of the research activity. 

Additionally, in the informed consent document, special care should be paid to ensure that students know that not participating in the research will not impact their course grade negatively nor impact their relationship with the professor. 

 

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Barring congressional oversight that may change how we understand social media companies and their role in content moderation, the University of Massachusetts Amherst’s Human Research Protection Office (HRPO) considers research utilizing social media (Twitter, Facebook, TikTok, public websites, etc.) involving no interaction or intervention with the individual about whom data are being collected (e.g., public Twitter feeds; public Facebook profiles or wall postings; information from public forums, open chat rooms, etc.) in most cases will not be considered Human Subjects Research as the federal regulations currently define it. While we consider most passive social media research (involving no interaction or intervention with the individual about whom data are being collected) Not Human Subjects Research, we strongly recommend that researchers follow these best practices:

  1. Research personnel should successfully complete human subjects ethics training. We recommend either Group 1: Biomedical research Investigators and Key Personnel - Basic Course; or, Group 2: Social Behavioral and Education Research Investigators and Key Personnel - Basic Course.
  2. If a post is not from a public figure, we strongly discourage quoting the social media posts verbatim since a simple query on a search engine will lead to the individual. When reporting findings, researchers should ensure that all the private information about an individual is removed. As a courtesy, we recommend that individuals not be individually identified or that the information on the individuals be combined in such a manner that the identity of the group or individuals cannot be readily ascertained.
  3. If needed, the researcher should submit a determination form to the HRPO office to seek a formal confirmation of not human participant research status for the study. However, depending on the nature of the study, the HRPO office may require a protocol submission out of an abundance of caution.

There is a strong argument to be made that social media posts are by and large meant to be public and engaged with (re-posted, shared, go “viral’, etc.). If an individual or social media platform has not placed any restrictions on access to information, that is, the information is available on a public website, blog, Twitter feed, open chat room, etc., the data should be considered as “publicly available” as understood by a general audience.[1]

We should acknowledge that there has been a healthy public debate regarding the role of social media in research with some pointing out that some data included in posts can indeed be private, not just about the post creator but about others (“doxxing,” intimate pictures, etc.).  Others voice concerns about whether a post’s use can actively harm the poster if highlighted in an academic setting. We must concede that currently, these platforms exist in an ambiguous space and that sometimes a “public” post or “public” settings may not indicate an active choice (“Participant” Perceptions of Twitter Research Ethics”). There is currently a lack of consensus in the field as to whether oversight is needed, as well as the proper way to collect, analyze, and report on social media data. It is possible that reputational harm could come not just to those directly quoted in academic research but third parties whose data may be disclosed in posts. Concerns over consent and privacy do not disappear simply because individuals participate in online social media networks and because the current human subjects research federal regulations do not seem to apply. In the past, out of an abundance of caution, our office has erred on the side of some oversight but at the lowest possible risk category (Exempt category).

Lastly, we should also point out that the IRB looks not only to the Code of Federal Regulations but also to the spirit of the Belmont Report and IRB members’ own sense of ethical conduct. Since the regulations do not cover everything, and emerging technologies raise novel issues and concerns, IRBs are given quite a bit of leeway as a body that represents not only researchers but also includes non-scientists, and community members. 

If you have any questions or concerns regarding any aspect of this policy guidance please contact us by phone at 9413) 545-3428 or via email at humansubjects@ora.umass.edu.

References

UC Santa Barbara’s “In line with online research guidance”.

Cornell University’s “Use of Social Networking Sites or Mobile Devices for Human Participant Research”.

NIH National Library of Medicine Blog “On the Ethics of Using Social Media Data for Health Research”.


[1] If an individual has restricted access to the data in any way or the social media platform or site has restrictive provisions in its terms of service, an expectation of privacy has been established and the investigator must seek IRB approval before conducting the research (e.g., the researcher has to request or seek access from the individual or from the group that the individual belongs to, If the researcher has to belong to, be invited to, or invite others to a particular “interest” or “friend” group, etc.).

Release Info: 

Effective Date: March 8, 2022

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Physician Clearance Policy

Physician Clearance Policy

Effective Date:02-02-2021
Revision Date:

I. Purpose

To provide a rationale for requiring physician clearance for certain participant populations prior to enrolling in a study, and describe all procedures associated with requesting physician clearance.

II. Policy Statement

In certain instances, the Institutional Review Board (IRB) may require researchers to request that an individual be “cleared” for participation prior to enrolling in a study. This step is most often required when the IRB is concerned for the safety of a subset of participants and mandates that certain individuals or class of individuals consult a medical professional, in most cases the individual’s Primary Care Provider, prior to being enrolled in a study.

III. Scope

There is no specific set of procedures in a protocol that may trigger the IRB to mandate physician clearance, the requirement will issue from the specifics of the study, the targeted population, and concerns arising during IRB deliberations. The IRB will inform researchers when the requirement to obtain a formal, signed physician clearance is a requirement for a protocol.

IV. Definitions

Physician clearance: A formal document signed by a medical professional attesting that an individual may safely participate in the study described in that document (please see attached Physician Clearance Template)

Physician: Unless otherwise noted, the IRB expects the physician to be the individual’s Primary Care Provider; however, physician clearance can be delegated to another medical professional duly authorized to provide medical advice, including a study physician.

V. Implementation

During the protocol review process, the IRB will communicate to researchers the need to acquire physician clearance for certain participants. The IRB will provide a Physician Clearance Template form which will be the only authorized manner in which the physician clearance will be recorded. Researchers will have the option of having potential participants approach their own physician(s) with the form and request physician clearance to participate in the research described. With participant permission, the researcher may also contact the physician(s) directly to request the signed clearance.

With regards to multi-year longitudinal studies, the IRB will request that researchers renew physician clearance annually. To clarify, researchers must request that the Physician Clearance form be signed by an authorized medical professional on an annual basis to ensure that participant are still eligible to participate in the longitudinal study.

Physician clearance is a requirement for participants deemed especially vulnerable by the IRB, as such, IRB representatives will have enhanced oversight of all studies requiring physician clearance.As part of the enhanced oversight, IRB representatives will conduct bi-annual either on-site or remote visits and request all physician clearance forms for review. The IRB retains the right to requests copies of physician clearance forms and other study materials at any point to ensure approved protocols are being adhered to for safety.

VI. Attachments

Physician Clearance Template

 

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Release Info: 

02-02-2021

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